法规知识库 · EMA 集中审评
Nexavar
sorafenib · EMEA/H/C/000690 · 已授权
获批上市许可
2006-07-19
欧委会决定日
2025-02-13
持有人 / 申请人
Bayer AG
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
8
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L01EX02
治疗领域：Carcinoma, Hepatocellular;Carcinoma, Renal Cell
药理分类：Antineoplastic agents
修订号：35 · 最新影响 PI 的程序：II/0059
适应症（原文）：Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2025-02-13 · 欧委会决定
2006-07-19 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Nexavar : EPAR - Risk Management Plan
rmp · 2025-03-28
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Nexavar : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-03-28
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Nexavar-H-C-690-PSUV-37 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-01-20 · EMA/754485/2014
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Nexavar-H-C-690-II-35 : EPAR - Assessment Report - Variation
variation-report · 2014-06-18 · EMA/CHMP/220738/2014
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Nexavar : EPAR - Summary for the public
overview · 2014-06-18 · EMA/391638/2011
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Nexavar-H-C-690-II-05 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-12-18
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Nexavar : EPAR - Scientific Discussion
scientific-discussion · 2007-03-05
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Nexavar : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2007-03-05
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。